The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Cytoplast Titanium-reinforced Ptfe Membranes.
| Device ID | K201187 |
| 510k Number | K201187 |
| Device Name: | Cytoplast Titanium-Reinforced PTFE Membranes |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock, TX 79424 |
| Contact | Shane Shuttlesworth |
| Correspondent | Shane Shuttlesworth Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock, TX 79424 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2021-01-23 |